EFFECTIVE AND BINDING AGREEMENT Sample Clauses
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EFFECTIVE AND BINDING AGREEMENT. Indivior and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Indivior’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
D. The undersigned Indivior signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity and that they are authorized to execute this CIA.
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically-transmitted signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇ (▇▇▇▇▇) ▇▇▇▇▇▇ DATE Chief Integrity & Compliance Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ DATE Chief Legal Officer Indivior, Inc. /▇▇▇▇▇▇ ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Lovells US LLP Counsel for Indivior /▇▇▇▇ ▇. Re/ 7/23/2020 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 7/24/2020 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇, Senior Counsel DATE ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Senior Counsel Office of Inspector General U.S. Department of Health and Human Services This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA.
EFFECTIVE AND BINDING AGREEMENT. Center for Pain Management and OIG agree as follows:
A. This IA shall become final and binding on the date the final signature is obtained on the IA.
B. This IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this IA.
C. OIG may agree to a suspension of Center for Pain Management’s obligations under this IA based on a certification by Center for Pain Management that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Center for Pain Management is relieved of its IA obligations, Center for Pain Management shall be required to notify OIG in writing at least 30 days in advance if Center for Pain Management plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the IA will be reactivated or modified.
D. All requirements and remedies set forth in this IA are in addition to and do not affect: (1) Center for Pain Management’s responsibility to follow all applicable Federal health care program requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program requirements.
E. The undersigned ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇.▇. ▇▇▇▇▇▇▇▇▇ represents and warrants that she is authorized to execute this IA. The undersigned OIG signatories represent that they are signing this IA in their official capacity and that they are authorized to execute this IA.
F. This IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same IA. Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this IA. /▇▇▇▇▇▇▇ ▇▇▇▇▇/_ 4/29/20 ▇▇▇▇▇▇▇ ▇▇▇▇▇, M.D. DATE /▇▇▇▇▇▇▇ ▇▇▇▇▇/ 4/29/20 Center for Pain Management, S.C. DATE /▇▇▇▇▇ ▇. ▇▇▇▇▇▇ ▇▇▇▇/ _4/29/20_ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇ ▇▇▇▇ DATE ▇▇▇ ▇▇▇▇▇▇▇ & ▇▇▇▇▇, s.c. /▇▇▇▇ ▇. Re/ 05/01/2020 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U. S. Department of Health and Human Services /▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇/ 05/01/2020 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇ DATE Associate Counsel Office of Inspector...
EFFECTIVE AND BINDING AGREEMENT. Halifax and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. OIG may agree to a suspension of Halifax’s obligations under this CIA based on a certification by Halifax that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. § 1320a-3, in any entity that bills any Federal health care program. If Halifax is relieved of its CIA obligations, Halifax will be required to notify OIG in writing at least 30 days in advance if Halifax plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA will be reactivated or modified.
D. The undersigned Halifax signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity and that they are authorized to execute this CIA.
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇ ▇▇▇▇▇▇/ 3/10/14 ▇▇▇▇ ▇▇▇▇▇▇ DATE President & Chief Executive Officer Halifax Health /▇▇▇▇▇ ▇▇▇▇▇▇▇▇/ 3/10/14 ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ DATE General Counsel Halifax Hospital Medical Center /▇. ▇▇▇▇ ▇▇▇▇▇▇▇▇/ 3/10/14 ▇. ▇▇▇▇ ▇▇▇▇▇▇▇▇ DATE ▇▇▇▇▇▇▇▇▇ Will & ▇▇▇▇▇ LLP Counsel for Halifax Health /▇▇▇▇ ▇▇▇▇▇▇/ 3/10/14 ▇▇▇▇ ▇▇▇▇▇▇ DATE President & Chief Executive Officer Halifax Health /▇. ▇▇▇▇ ▇▇▇▇▇▇▇▇/ 3/10/14 ▇. ▇▇▇▇ ▇▇▇▇▇▇▇▇ DATE ▇▇▇▇▇▇▇▇▇ Will & ▇▇▇▇▇ LLP Counsel for Halifax Health /▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 3/10/14 ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 3/9/2014 ▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE Senior Counsel Office of Counsel to the Inspector General U.S. Department of Health and Human Services /▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇/ 3/7/2014 ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ DATE Senior Counsel Office of Counsel to the Inspector General U.S. Department ...
EFFECTIVE AND BINDING AGREEMENT. ▇▇▇▇▇▇▇▇ and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. OIG may agree to a suspension of ▇▇▇▇▇▇▇▇’▇ obligations under this CIA based on a certification by ▇▇▇▇▇▇▇▇ that it is no longer providing health care items or services that will be billed to any Federal health care program and that it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If ▇▇▇▇▇▇▇▇ is relieved of its CIA obligations, ▇▇▇▇▇▇▇▇ will be required to notify OIG in writing at least 30 days in advance if ▇▇▇▇▇▇▇▇ plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA will be reactivated or modified.
D. The undersigned ▇▇▇▇▇▇▇▇ signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacities and that they are authorized to execute this CIA.
E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇ ▇▇▇▇▇▇/ 5/6/2014 ▇▇▇▇ ▇▇▇▇▇▇ DATE President and Chief Executive Officer ▇▇▇▇▇▇▇▇ Laboratories, Inc. /▇▇▇▇▇▇ ▇. ▇▇▇▇▇, Esquire/ 05/06/2014 ▇▇▇▇▇▇ ▇. ▇▇▇▇▇, Esquire DATE Vice President & Chief Compliance Officer ▇▇▇▇▇▇▇▇ Laboratories, Inc. /▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇▇, Esquire/ 5/7/2014 ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇▇, Esquire DATE ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, Esquire ▇▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇, Esquire Skadden, Arps, Slate, ▇▇▇▇▇▇▇ & ▇▇▇▇, LLP Counsel for ▇▇▇▇▇▇▇▇ Laboratories, Inc. /▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 5/15/14 ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ DATE Assistant Inspector General for Legal Affairs Office of Inspector General U. S. Department of Health and Human Services /▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ Berlin/ 5/1/14 ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ BERLIN DATE Senior Counsel Office of Inspector General U. S. Department of Health and Human Services /▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇/ 5/9/14 ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ DATE Senior Counsel Office of Inspector General U. S. Department of Health and Human Servic...
EFFECTIVE AND BINDING AGREEMENT. ▇▇▇▇▇▇▇ and OIG agree as follows:
A. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
B. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) ▇▇▇▇▇▇▇’s responsibility to follow all applicable Federal health care program requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program requirements.
C. The undersigned ▇▇▇▇▇▇▇ signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacities and that they are authorized to execute this CIA.
D. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. U.S. Department of Health and Human Services U.S. Department of Health and Human Services APPENDIX A INDEPENDENT REVIEW ORGANIZATION This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.D of the CIA.
A. IRO Engagement
1. Lincare shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the reviews in a professionally independent and objective fashion, as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.8 of the CIA or any additional information submitted by ▇▇▇▇▇▇▇ in response to a request by OIG, whichever is later, OIG will notify Lincare if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare may continue to engage the IRO.
2. If Lincare engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, ▇▇▇▇▇▇▇ shall submit the information identified in Section V.A.8 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Lincare at the request of OIG, whichever is later, OIG will notify Lincare if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Lincare may continue to engage the IRO.
B. IRO Qualifications T...
EFFECTIVE AND BINDING AGREEMENT. C▇▇▇▇ and OIG agree as follows:
A. This CCA shall be binding on the successors, assigns, and transferees of Coram;
B. This CCA shall become final and binding on the date the final signature is obtained on the CCA;
C. This CCA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CCA;
D. ▇▇▇ may agree to a suspension of C▇▇▇▇’▇ obligations under this CCA in the event of C▇▇▇▇’▇ cessation of participation in Federal health care programs. If C▇▇▇▇ withdraws from participation in Federal health care programs and is relieved of its CCA obligations by OIG, Coram shall notify OIG at least 30 days in advance of Coram’s intent to reapply as a participating provider or supplier with any Federal health care program. Upon receipt of such notification, OIG shall evaluate whether the CCA should reactivated or modified.
E. The undersigned Coram signatories represent and warrant that they are authorized to execute this CCA. The undersigned OIG signatory represents that he is signing this CCA in his official capacity and that he is authorized to execute this CCA.
F. This CCA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CCA. Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CCA. /S/ 8/21/07 M▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇ Corporate Compliance Officer Senior Vice President, Quality, Ethics and Compliance /S/ 8/21/07 J▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇, H▇▇▇▇& H▇▇▇▇▇▇, LLP COUNSEL FOR CORAM, INC. /S/ 8/21/07 G▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ Assistant Inspector General for Legal Affairs Office of Inspector General United States Department of Health and Human Services The declarant is currently the Corporate Compliance Officer of Coram, Inc. and has personal knowledge of the facts stated herein. The following describes the compliance program (Program) currently in place at Coram.
EFFECTIVE AND BINDING AGREEMENT. Ventura County and OIG agree as follows:
A. This CIA shall become final and binding on the date the final signature is obtained on the CIA.
B. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
C. OIG may agree to a suspension of Ventura County’s requirements under this CIA based on a certification by Ventura County that it is no longer providing health care items or services that will be billed to any Federal health care program and it does not have any ownership or control interest, as defined in 42 U.S.C. §1320a-3, in any entity that bills any Federal health care program. If Ventura County is relieved of its CIA requirements, Ventura County shall be required to notify OIG in writing at least 30 days in advance if Ventura County plans to resume providing health care items or services that are billed to any Federal health care program or to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA will be reactivated or modified.
D. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Ventura County’s responsibility to follow all applicable Federal health care program requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program requirements.
E. The undersigned Ventura County signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacities and that they are authorized to execute this CIA.
F. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA.
EFFECTIVE AND BINDING AGREEMENT. Tauth and OIG agree as follows:
A. This IA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this IA.
B. All requirements and remedies set forth in this IA are in addition to and do not affect: (1) Tauth’s responsibility to follow all applicable Federal health care program requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program requirements.
C. The undersigned Tauth signatory represents and warrants that [he/she] is authorized to execute this IA. The undersigned OIG signatories represent that they are signing this IA in their official capacity and that they are authorized to execute this IA.
D. This IA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same IA. Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this IA. 12-20-22 /▇▇▇▇▇▇▇ ▇▇▇▇▇, MD/ ▇▇▇▇▇▇▇ ▇▇▇▇▇, M.D. 12/28/2022 Office of Inspector General U. S. Department of Health and Human Services APPENDIX A INDEPENDENT REVIEW ORGANIZATION This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.C of the IA.
A. IRO Engagement
EFFECTIVE AND BINDING AGREEMENT. Provider and OMIG agree as follows:
A. Good and valuable consideration has been exchanged between the parties to this CIA.
B. This CIA shall become final and binding on the date the final signature is obtained on the CIA as established in Section II. A.
C. This CIA shall be considered to include the Corporate Integrity Agreement and any Appendix, Attachment or Amendment to this CIA which is in writing and executed by the parties to this CIA. They shall collectively constitute the entire and complete agreement between the parties and may not be amended except by prior written consent of the parties to this CIA, or as may be otherwise permitted.
D. The terms of any Appendix, Attachment or Amendment to the CIA shall be incorporated by reference as if fully set forth in this CIA. If there is any conflict between a term in the CIA and any Appendix, Attachment or Amendment, the terms of the CIA shall control unless otherwise specifically stated in the terms of the Appendix, Attachment or Amendment.
E. This CIA shall be binding on the successors, assigns, and transferees of Provider.
F. All requirements and remedies set forth in this CIA are in addition to, and do not effect:
1. Provider’s responsibility to follow all applicable New York State and Federal health care program requirements or
2. the State of New York’s or the federal government’s right to impose appropriate remedies for failure to follow applicable program requirements.
G. The undersigned Provider signatories represent and warrant that they are authorized to execute this CIA. The undersigned OMIG signatory represents that he/she is signing this CIA in his/her official capacity and that he/she is authorized to execute this CIA.
H. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA.
EFFECTIVE AND BINDING AGREEMENT. Advanced Bionics and OIG agree as follows:
A. This CIA constitutes the complete agreement between the parties and may not be amended except by written consent of the parties to this CIA.
B. All requirements and remedies set forth in this CIA are in addition to and do not affect (1) Advanced Bionics’s responsibility to follow all applicable Federal health care program and FDA requirements or (2) the government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements.
C. The undersigned Advanced Bionics signatories represent and warrant that they are authorized to execute this CIA. The undersigned OIG signatories represent that they are signing this CIA in their official capacity and that they are authorized to execute this CIA.
D. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Electronically transmitted copies of signatures shall constitute acceptable, binding signatures for purposes of this CIA. /▇▇▇▇ ▇▇▇▇▇▇▇▇/ _ 12/16/22 ▇▇▇▇ ▇▇▇▇▇▇▇▇ DATE Vice President, Global Legal Affairs Advanced Bionics LLC /▇▇▇▇▇▇▇ ▇. ▇’▇▇▇▇▇▇/ 12/16/22 ▇▇▇▇▇▇▇ ▇’▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇ LLP Counsel for Advanced Bionics LLC /▇▇▇▇ ▇. Re/ 12/14/2022 ▇▇▇▇ ▇. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U.S. Department of Health and Human Services /▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇/ 12/19/2022 ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ DATE Senior Counsel This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.D of the CIA.